You are here
Generic Version of Zonegran Passes FDA Muster
December 23, 2005
PITTSBURGH, Dec. 23 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE:MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zonisamide Capsules, 25 mg, 50 mg, and 100 mg. Zonisamide Capsules are the AB-rated generic equivalent of Dainippon Pharmaceutical's Zonegran(R) Capsules, which had U.S. sales of approximately $171 million for the 12-month period ending June 30, 2005, according to IMS Health.
This product will begin shipping immediately.
Source: The Food and Drug Administration
One in Five Kids’ Office Visits Results in an Off-Label Rx
Related Settlement Would End Many but Not All Lawsuits
Chronic Kidney Patients With Hyperphosphatemia May Be Another Market for the Drug
Nitrosamine Impurity Also Affects Other Ranitidine Drugs
Mesh Implants, Now Banned by FDA, Work as Well as Hysterectomy
Judicious Use of Antibiotics May Not Be Enough To Defeat Bacteria That Carry On By Going Into a Dormant State
KRAS Oncogene Is a Problematic Target So Researchers Are Trying Workdarounds
Understanding Neural Ensembles in Infralimbic Cortex May Lead To Improved Addiction Treatment
Disrupting Gut Microbiome Could Be Key